PMDA drug package insert
リスペリドン錠1mg「ニプロ」
PMDA Prescription drug · 全星薬品工業株式会社 · package insert Dec 5, 2025
Key facts
| Brand names | リスペリドン錠1mg「ニプロ」, リスペリドン錠2mg「ニプロ」, リスペリドン錠3mg「ニプロ」, リスペリドン細粒1%「ニプロ」 |
|---|---|
| Nonproprietary names | リスペリドン |
| Companies | 製造販売元／全星薬品工業株式会社, 販売／ニプロ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗精神病剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179038F1201, 1179038F2208, 1179038F3190, 1179038C1183 |
| Approval numbers | 30700AMX00105, 30700AMX00106, 30700AMX00107, 30700AMX00108 |
| Package insert edition | 第1版 |
| Package insert date | Dec 5, 2025 |
| PMDA document key | 380087_1179038C1183_1 |
| PMDA company code | 380087 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- No PMDA review report published
- No Risk management plan (RMP)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMDA approved drugs and package inserts (Japan)
Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date: